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Job Details

This role is in support of Cencora's veterinary and livestock production solutions marketed through our MWI Animal Health business. MWI Animal Health is a leading brand of Cencora, offering animal health services globally.

Location: Remote, USA with travel required to facilities based in Idaho.

The Quality Specialist will report to the Senior Manager of Quality and Regulatory and will be responsible for quality systems and quality assurance activities for MWI compliance within addition support release of finished product and investigations of product related issues.

Duties and Responsibilities:

• Oversee the management, organization, maintenance and record retention of all controlled documents within the company’s quality management system (QMS)
• Ensure compliance with regulatory requirements, company policies, and industry standards, supporting the efficient operation of the development processes for MWI’s private brands
• Identify and implement process improvements to enhance the efficiency and effectiveness of the document control system
• Develop and maintain document control procedures, work instructions, and training materials
• Approve and execute all regulatory updates to product labelling to ensure timely & compliant launch of finished products
• Create and maintain National Drug Codes (NDC) & Universal Product Codes (UPC)
• Provide oversight of the deviation and CAPA programs, including tracking, trending, and periodic reporting of quality and adverse events
• Validate all packaging information, label artwork & print proof to ensure its compliance with applicable regulation and standards
• Participate in the development of Product Quality Assurance strategy to support company brands as well as contract manufacturing and supplier facilities 
• Participate in new product teams to bring products through the design control process to deliver on-time product launches 
• Provide support for quality audits, initial site approvals and due diligence activities
• Participate and lead product quality investigations to identify root cause and implement corrective actions
• Coordinate activities to support follow-up on complaint trend investigations for non-medical and medical (adverse events)
• Support the business quality risk management program through evolving current process, annual and interim review scheduling, ensuring escalation of any quality/critical control point failures and promoting completion of quality impact assessments as required to maintain business regulatory compliance.
• Develop the business validation program. Engage with key stakeholders regularly, review and sign off validation reports, engage with relevant departments to ensure that recommendations are closed out and actions documented.
• Support the business in change management through evolving current process, being actively involved in change impact assessment and promoting risk elimination/minimization as standard.
• Measure key performance indicators (KPIs) to monitor areas of responsibility and identify areas for improvement
• Drive functional data-driven activity through regular data review meetings to continuously improve service quality and regulatory compliance.
• Review quality trend data, propose and execute quality improvement projects utilizing lean and six sigma principles and promote throughout day-to-day activities within departmental teams.
• Support all quality engagement programs and have an active role in quality education & training initiatives.
• Perform related duties as assigned

Education:

• Bachelor's degree, preferably in healthcare or science discipline, is required.
• Certified Regulatory Compliance Manager (CRCM) preferred.

Experience:

• Three (3) or more years of professional experience in a healthcare setting, pharmaceutical company, or supporting clinical trials required.
• Experience with complex regulatory filing(s) and post-approval regulatory activities.
• Experience in auditing, risk management, and/or quality management.

Skills and Abilities:

• Excellent oral and written communication skills.
• Ability to effe